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Last Updated: December 14, 2024

SOTRET Drug Patent Profile


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When do Sotret patents expire, and what generic alternatives are available?

Sotret is a drug marketed by Sun Pharm Inds Ltd and is included in two NDAs.

The generic ingredient in SOTRET is isotretinoin. There are thirteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the isotretinoin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Sotret

A generic version of SOTRET was approved as isotretinoin by AMNEAL PHARMS NY on September 29th, 2017.

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Summary for SOTRET
Drug patent expirations by year for SOTRET
Recent Clinical Trials for SOTRET

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Children's Oncology GroupPhase 2
Children's Oncology GroupN/A
National Cancer Institute (NCI)N/A

See all SOTRET clinical trials

US Patents and Regulatory Information for SOTRET

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Inds Ltd SOTRET isotretinoin CAPSULE;ORAL 076041-001 Dec 24, 2002 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sun Pharm Inds Ltd SOTRET isotretinoin CAPSULE;ORAL 076041-003 Dec 24, 2002 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sun Pharm Inds Ltd SOTRET isotretinoin CAPSULE;ORAL 076041-002 Dec 24, 2002 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sun Pharm Inds Ltd SOTRET isotretinoin CAPSULE;ORAL 076503-001 Jun 20, 2003 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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